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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . June 13th, 2004

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Blood Safety - Transfusion-transmitted bacterial infection risks reviewed

Malaria Vaccine - Humoral response against Plasmodium vivax protein retained for 30 years

Multiple Sclerosis - Mice expressing myelin glycoprotein protected against encephalomyelitis

Salmonella - Antimicrobial use increases risk of drug-resistant Salmonella infection

Salmonella - Chicken consumption is risk factor for Salmonella infection in U.S.

AIDS/HIV Therapy - Nucleoside analogues and mitochondrial toxicity reviewed

Acute Myeloid Leukemia - Ceplene trial in AML meets primary trial endpoint

Adverse Event - Nationwide recall made of instructions for use of biliary stent

Alcoholism - Girls living with alcoholic stepfather have more behavior problems than boys

Amyotrophic Lateral Sclerosis - Pharmacological management of amyotropic lateral sclerosis reviewed

Anthrax - Anthim selected for testing by U.S. federal government

Anthrax Vaccine - Conjugate induces antibodies to capsule of B. anthracis

Anti-Infectives - Cyanovirin-N antiviral activity evaluated

Artery Closure - Device maker submits PMA for vascular closure system

Blood Safety - A new rapid molecular assay detects at least four strains of the SEN virus

Breast Cancer - CTLs to breast tumor-associated protein lyse breast cancer cells

Breast Cancer - FDA accepts NDA for Abraxane for treatment of metastatic breast cancer

Breast Cancer - Women who regularly use aspirin seem to have reduced cancer risk

Business Update - Company restructuring to focus on Genasense programs

Business Update - FDA approves Fluticasone Propionate Cream

Business Update - King reiterates commitment to launch and market Estrasorb

Business Update - Pharmion up as drug seen nearing FDA approval

Campylobacter - Chicken consumption is risk factor for Campylobacter infection in U.S.

Cancer Risk - Chemically induced tumors in laboratory animals may have human relevance

Cancer Therapy - FDA approval granted to investigate new cancer treatment applicator

Cardiac Arrhythmias - FrostByte receives FDA clearance, company poised to launch

Cardiovascular Disease - FDA approves rapid exchange catheter for coronary indications

Cervical Cancer - HPV vaccines and cervical cancer reviewed

Clinical Trials - Study reviews the evolution of statistical methods used with clinical trials

Contraception - FDA issues not approvable letter for over-the-counter emergency contraceptive

Cough - FDA approves Mucinex DM extended-release tablets

Device Sterilization - FDA approves hydrogen peroxide sterilization process

Diabetes Pathogenesis - Islet-specific glucose-6-phosphatase-related protein linked to diabetes

Diarrhea - Burden of self-reported acute diarrheal illness in 1998-1999 reported

Diet and Nutrition - Iron supplements help only certain women who are not anemic

Drug Addiction - Factors to retain drug-abusing women in residential therapy reported

Drug Addiction - Residential drug abuse for pregnant women improves birth outcomes

Drug Ban - Consumer advocate renews call for ban on cholesterol drug

Drug Development - Phase III clinical development for AQUAVAN Injection begins

E. Coli - Deletion in flhC gene causes nonmotility of E. coli 0157:H- strains

Emergency Contraception - Canada's government proposes access to levonorgestrel without a prescription

Emergency Contraception - Public health group renews call for improving access to 'morning-after pill'

Endoscopy - FDA issues 510(k) clearance for flexible video-enabled endoscope

Environmental Health - Organochlorines determined in human biological samples by GC-MS/MS

Environmental Health - Solvent systems compared for analysis of organochlorines in fish tissue

Exposure Payouts - New rule to help weapons workers comes under fire

Finance - Biopharma reports Q1 revenues of $0.7 million, net loss of $4.8 million

Fitness and Wellness - Advocates fear global diet and exercise strategy may be derailed

Food-Borne Illness - Analyses of stool samples should include testing for E. coli O157:H7

Food-Borne Illness - Chicken giblets from Costa Rica increase risk of E. coli O157:H7

Food-Borne Illness - Epidemiologic issues in study design of FoodNet activities outlined

Gastrointestinal Disease - Drug candidate may help treat irritable bowel syndrome

Genetically Modified Crops - U.N. food agency still supports genetically modified crops

Genomics - GeneExpress data to support CDER genomics study

HIV/AIDS Treatment - AIDS medicine price hike may lead to licenses to other companies

HIV/AIDS Treatment - Big pharmaceutical companies pledge to work on AIDS drug

HIV/AIDS Treatment - State AIDS drug plans offering widely varying benefits

Health Research - Former NIH director says easing rules improved recruiting

Healthcare Costs - HMS signs Care1st as client, grows Medicaid managed care business

Healthcare Costs - ITAA: Chronic care improvements could net over $30B in Medicare savings

Healthcare Coverage - North Carolina spending committee hears options on HHS reductions

Healthcare Coverage - Oregon researchers find Americans pay more for health care, feel worse

Hepatitis B Virus - Diversity of hepatitis B virus in Dutch blood donors reported

Hookworm -  Ancylostoma ceylanicum protein shows promise for hookworm vaccine

Hookworm - Serine protease inhibitor linked to hookworm-associates growth delay

Huntington Disease - Paroxetine retards disease onset in huntingtin mutant mice

Immunology - Antigen Express wins Japanese patent for certain Ii-Key compounds

Influenza - New influenza immunization guidelines hailed by vaccine maker

Influenza - Study: Intranasal influenza vaccine shows higher efficacy rate

Influenza Virus - Influenza A virus PB1-F2 gene reported in recent Taiwanese isolates

Kidney Transplant - Biomarkers and surrogate endpoints in renal transplantation reviewed

Legal Issues - House panel looks at possible conflict of interest at Pitt

Leishmaniasis - Gene encoding protective Leishmania amazonensis protein characterized

Leishmaniasis - L14 ribosomal protein from Leishmania braziliensis characterized

Lung Cancer - New classification schemes improve the utility of murine lung cancer models

Migraines - Pilot study begins using faster acting version of sumatriptan

Military Emergency Procedures - Ohio case prompts Army to adopt new policy when contacting families

Multiple Sclerosis - Trial investigates MS treatment with Gamunex

Mumps - Analysis of mumps virus isolates during Swiss outbreak reported

Mumps - Study of mumps outbreak due to genotype H in Korea in 1999 reported

Mumps - Two new genotypes of mumps virus in Japan proposed

Neisseria - PorA variable regions of Neisseria meningitidis characterized

Oncogenesis - CDC91L1 is newly discovered oncogene in human bladder cancer

Pancreatic Islets - Resistin levels return to normal after islet transplantation

Parasitology - Clinical laboratory practices for parasitic diseases surveyed

Parkinson's Research - Little Rock cardiologist embarking on Parkinson's research

Pediatric Health - Doctors say cap could help reverse brain damage in newborns

Personnel - Paul Wehrle, researcher who helped eradicate smallpox, dead at 82

Polio Vaccine - African nations step up polio battle as vaccine opponents signal end to boycott

Prescription Drugs - Seniors group files lawsuit over Canada imports

Prostate Cancer - IsoRay to manufacture Cesium-131 brachytherapy seed through new contract

Prostate Cancer - Special protocol assessment granted from FDA for trial of GVAX vaccine

Proteomics - Mass spectrometry gas-phase fractionation enhances protein identification

Public Health - Primary enforcement seat belt laws are effective

Radiotherapy - Halofuginone lessens the profibrotic effects of high-dose radiation

Regulatory Oversight - Pharmaceutical packaging company achieves FDA CFR compliance

Reproductive Medicine - Researchers identify gene linked to sperm-producing stem cells in mammals

Respiratory Care - FDA clearance granted to market oxygen therapeutic device

SARS - China's latest SARS outbreak declared contained

Safety Testing - Cardiovascular safety assessment service launched

Salmonella - Eggs are main risk factor for Salmonella Heidelberg infections

Salmonella - Hospitalizations and deaths due to Salmonella infections reported

Salmonella - Nontyphoidal Salmonella infections are significant burden in U.S.

Schistosomiasis - Dexamethasone improves parameters in chronic schistosomiasis

Sexually Transmitted Diseases - Use of vaginal diaphragm to prevent STDs acceptable to women in study

Skin Cancer - Alpha-tocopherol may offer some protection against less aggressive melanomas

Skin Itch, Inflammation - FDA grants approval to market fluticasone cream

Stem Cells - Britain opens world's first national stem cell bank

Tick-Borne Disease - Titration of Theileria parva tick-derived stabilates reported

Tobacco Ban - Massachusetts health department targets flavored cigarettes

Tuberculosis - Temporal expression profile of M. tuberculosis infection reported

Vasomotor Symptoms - FDA approval granted for Enjuvia (synthetic conjugated estrogens)

Virology - Mechanisms and biomedical applications of virus entry reviewed

West Nile Virus - Pathogenesis and therapeutic options for West Nile virus reviewed

West Nile Virus - West Nile Virus education campaign targets older Nebraskans

Workers Health and Safety - House approves changes to government's work-safety agency

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